CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
PrisMax V3 control Unit-US, Hemodialysis Delivery System recalled
Vantive US Healthcare is recalling PrisMax V3 control Unit-US, Hemodialysis Delivery System. The recall was initiated on 28 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2438-2025
- FDA event ID
- 97233
- Recalling firm
- Vantive US Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Jul 2025
- FDA classified
- 26 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 28 Jul 2025 | Recall initiated by company | |
| 26 Aug 2025 | Classified by FDA | +29 days |
| 3 Sep 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Where it was distributed
Worldwide
Questions about this recall
Why was it recalled?
Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure
Which lots are affected?
UDI 07332414126018, All serial numbers
Where was it sold?
Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97233This product is part of a recall event; the main page for the event is PrisMax V2-US, Hemodialysis Delivery System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | PrisMax V2-US, Hemodialysis Delivery System recalled | Vantive US Healthcare | Device Malfunction | IL | |
| CLASS II | TherMax Blood Warmer Unit-US, PrisMax Accessory recalled | Vantive US Healthcare | Device Malfunction | IL |
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